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Generated: June 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209862

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NDA 209862 describes EVZIO (AUTOINJECTOR), which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from one supplier. There are twenty-six patents protecting this drug. Additional details are available on the EVZIO (AUTOINJECTOR) profile page.

The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 209862
Tradename:EVZIO (AUTOINJECTOR)
Applicant:Kaleo Inc
Ingredient:naloxone hydrochloride
Patents:26
Formulation / Manufacturing:see details
Pharmacology for NDA: 209862
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 209862
Suppliers and Packaging for NDA: 209862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862 NDA kaleo, Inc. 60842-051 60842-051-01 2 DOSE PACK in 1 CARTON (60842-051-01) > .4 mL in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength2MG/0.4ML (2MG/0.4ML)
Approval Date:Oct 19, 2016TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 24, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
Patent:➤ Try a Free TrialPatent Expiration:Jun 1, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 15, 2025Product Flag?YSubstance Flag?Delist Request?

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